Frage an die Gen/Biotech Profis: Was haltet Ihr von Super Gen ?. Push oder eine echte

Perle?.

It's impossible to lump the solutions proposed by AVI BioPharma (NASDAQ:AVII) into one category. The easiest way to classify the company's divisions is by the various technology platforms each uses. Each platform could easily qualify for its own company - or at the very least, its own story. Technologies already being tested at AVI BioPharma seem to be working even without the Celera Genomics (NYSE:CRA) map of the human genome - a draft of which was announced completed just this week.AVI's patent portfolio includes the exciting drugs Avicine, NeuGene and 42 other patents.At least one of AVI's drugs will be entering Phase III testing within the next few months, putting AVI that much closer to the billion dollar market opportunities the company is targeting.

Avicine's Advantage

Avicine, the cancer vaccine being developed by AVI that is now undergoing trials, makes use of the naturally occurring hormone hCG, human chorionic gonadotropin. This hormone is manufactured by the human body in two circumstances. During pregnancy, hCG protects the fetus (ordinarily the body would expel foreign growths). Also, hCG aids the fetal development by stimulating cell division and rapid cell growth. The sheer mass of a fetus requires angeogenesis, the forming of blood vessels to transmit oxygen throughout the fetus; this function is also stimulated by hCG. Retaining these primary functions, hCG enables the fetus to grow to 6 or 7 pounds in 9 months. The World Health Organization (WHO) currently tests hCG vaccines in Third World countries for birth control purposes.

The other instance in which hCG will be produced in the body is during the presence of any form of cancer. The hormone hCG serves the same purpose here as in pregnancy - protecting the foreign growth from the immune system, and stimulating rapid cell division and growth while promoting angeogenesis. AVI's clinical trials revealed that the administration of an hCG-suppressing vaccine leads to a dramatic reduction in the activities that the hormone promotes. The result is a restraint not only of angeogenesis, but also of cell division - which means a smaller tumor.

AVI's Avicine will be going into Phase III colorectal trials; companies who have come this far typically gain FDA approval for their drugs. Phase II testing will soon be underway for prostate cancer. A significant advantage in this industry is that "off-label" prescription of the vaccine is permitted regardless of which particular cancer the drug is first approved for sale for by the FDA. The implication here is that although the label may read, "tested as effective against colorectal cancer," a patient is more than welcome to use it for breast cancer and, more important, a doctor is allowed to prescribe it for any cancer.

The worldwide market opportunity for a platform of cancer vaccines is enormous - estimated at roughly one billion dollars for each type of cancer. Results show 51 of 77 patients in Phase II colorectal trials had a median survival of 42 weeks, which far surpassed the 16-week survival rate for patients treated with chemotherapy alone. The type of cancer patient that is accepted for and willing to submit to experimental drug testing is in as poor a shape as imaginable - typically the patient has failed all other possible avenues of cancer treatment. With vaccine treatments responding to both hCG targets, median survival was 66 weeks; much better than the 34 to 40 weeks offered by chemotherapy.

Secondary Phase II testing of the hCG-suppressing vaccine in pancreatic cancer patients will be done in conjunction with Eli Lilly's (NYSE:LLY) popular Gemzar chemotherapy drug. The last round of such testing on a limited number of patients was conducted in the absence of complimentary chemotherapy and resulted in a median survival of 33 weeks. Patients using chemotherapy alone had a median survival of 25 weeks. Generally speaking, the FDA is much more likely to approve a drug if it has been found to perform better than chemotherapy. With this thought in mind, consider how the FDA has given permission for AVI to work with first-line therapy patients in upcoming Phase III trials- this signals strong confidence in the safety of the treatment on the part of the FDA.Further, these patients have not degraded their immune systems with harsh available treatments, and tend to have improved response to any treatment in their healthier bodies - a trend AVI hopes to extend.

What AVI brings the patient through Avicine is "quality of life." Side effects for the leading chemotherapy treatments range from nausea to hair loss and even death. For Avicine patients, general side effects mirrored those of a childhood vaccination: some patients experienced temporary swelling and redness at the site of injection. Avicine's targeting nature is a non-toxic treatment, and is perceived to be highly efficacious when used by healthier patient groups. The vaccine has proven to be decidedly advantageous when used as a second line treatment with other therapeutics.

Since AVI products seem to work thus far in conjunction with chemotherapy drugs, the company will be protected in the coming years from hostility from the mega-corporations in the pharmaceutical industry who can apply significant market pressure should they see a competitor's medication stealing market share. This would accommodate AVI's leveraging of its product alongside Lily's Gemzar or Pharmacia & Upjohn's (NYSE:PHA) Camptosar, two leading chemotherapy treatments.

NeuGene - Antisense

The future of AVI's prominence in the biotech industry lies in its work with gene-targeted therapeutics - namely, its NeuGene technologies. Yesterday, the company announced that it has initiated Phase II human clinical trials of Resten-NG. NeuGene will be evaluated in trials to treat cardiovascular restenosis (a common consequence of balloon angioplasty procedures). The technology constitutes the second platform through which AVI will be able to introduce, manufacture and sell an innovative product that is poised to have a major impact on the struggle against human disease.

The NeuGene mechanism, which can be applied to any exposed genetic target, functions as a block to ribosomal assemblies, thereby preventing production of disease-causing proteins. The NeuGene target, oncogene c-myc, promotes tumor growth. By targeting this transcription factor, the treatment is believed to be applicable to a wide variety of proliferative diseases - the most obvious of which are restenosis (affecting 200,000 Americans yearly) and cancer (the second leading cause of death in the United States). Again, targeting disease at a genetic level inhibits the problem in a safe and effective manner.

The treatment development is still at an early stage - it just entered phase II for the most advanced application. However, the NeuGene technology heralds a new age in biotechnology and disease therapies. With great strides being made toward completing the mapping process of the human genome, the multifunctional third generation platform will attract a lot of attention in the years to come. Looking into the future, this technology could potentially spin-off numerous applications, generating a healthy product portfolio in equally healthy markets.

CytoPorter

Drug movement across membranes, into the interior of cells, is more difficult than it may seem. In order to traverse the various cellular barriers and reach targets, drugs typically must exhibit the characteristics of being both a lipid and water-soluble. Unless a compound possesses these traits, the effectiveness of any dosage is compromised and may increase the risk of toxicity to the patient as greater levels of the treatment are administered to ensure delivery. A number of developmental stage drugs have delivery problems, and many will never even see clinical testing because of this limitation.

AVI's CytoPorter, a transport mechanism still in very early stages of development, was designed with these problems in mind. The CytoPorter carries polar and larger-sized drugs through skin or cell membranes without damaging the cell membrane at all. The initial studies have revealed that this treatment is best used for the systematic delivery of insoluble drugs used in cancer therapy and anti-rejection transplantation drugs. Also, the CytoPorter is believed to be effective in transdermal delivery of drugs in the treatment of psoriasis, melanoma and basal cell carcinoma.

Looking to the Future

For the marketing of AVI's Avicine, SuperGen, Inc. (NASDAQ:SUPG), has already invested $25 million in cash and SUPG stock in return for exclusive sales and marketing rights for the vaccine in the United States. The company is currently considering international partners for marketing and sales. The big advantage to AVI choosing a smaller player in the industry is in the profit-split and cost-sharing stipulations - a 50/50 split in the SuperGen case compared to the 85/15 that the major drug companies generally offer.

AVI's partnerships - some of which are outside the oncology sector - demonstrate the broad range of interest in the company's products. With XTL Therapeutics, AVI is just starting to take advantage of the universality of the treatment ability of its technologies. One exciting example of this is the extension of the NeuGene antisense line into therapeutics for hepatitis B and C. The XTL development "engines" and animal test models being used to verify AVI drugs are also used at Eli Lilly and Hoffman-La Roche. Also exploring potential delivery strategies of the NeuGene drug with AVI is DepoMed (AMEX:DMI), which specializes in drug absorption into the gastric system. The third generation antisense drug line is a synthetic molecule, and there are indications that it can be engineered into pill form (pills are less painful for the patient, more convenient, and cheaper).

The announcement yesterday concerning the beginning of Phase II trials for AVI's Resten-NG treatment should serve to compound interest in the company and generate widespread confidence that the company is moving ahead according to schedule- yesterday's significant stock price jump corroborates this. A secondary offering that will generate an extra $30 million in cash for the company will buttress finances in order to sustain the upcoming period of expensive Phase III testing of Avicine. The company has surmounted most major hurdles that would typically halt the progress of a biotech firm, such as finding major partners or adequate financing. Though the road is by no means fast and furious from here, advances in genomic expertise, a robust product pipeline and the realization of advanced clinical trials combined, make the company look much like a "rocket on a launch pad" - and should carry AVI BioPharma to a glittering future.

... sind vorallem im Leukämiebereich tätig.
Unter www.recap.com, dann auf "CLINICALS" klicken und "Supergen" eintippen,
kannst du sehen welche Medikamente sich in deren Pipeline befinden. Zwei sind sogar Marktreif und mehrere in Phase II und III.
Ich habe den Wert zwar nicht, ist aber aufjedenfall interessanter als Medarex.
Drei-Vier Biotechs gehören in jedes Depot, Supergen scheint eine gute Wahl zu sein. Ich habe zur Zeit Vertex, Lexicon Genetics, ID Biomedical und Medigene

so long, doous